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磺达肝癸钠用于肝素诱导的血小板减少症血液透析患者的安全性和有效性:一项系统评价

Safety and efficacy of fondaparinux use in hemodialysis patients with heparin-induced thrombocytopenia: a systematic review.

作者信息

Stojadinovic Milorad, Jankovic Slobodan, Zivkovic-Zaric Radica, Baralic Marko, Jovicic-Pavlovic Svetlana, Bontic Ana, Petrovic Nemanja, Pejcic Ana

机构信息

Clinic of Nephrology, University Clinical Centre of Serbia, 11000, Belgrade, Serbia.

Clinical Pharmacology Department, University Clinical Centre Kragujevac, 34000, Kragujevac, Serbia.

出版信息

Eur J Clin Pharmacol. 2025 Sep 9. doi: 10.1007/s00228-025-03913-8.

Abstract

BACKGROUND

Heparin-induced thrombocytopenia (HIT) is a severe primary hypercoagulable disorder, particularly concerning in hemodialysis (HD) patients frequently exposed to heparin. Fondaparinux has emerged as a potential alternative anticoagulant, though supporting evidence is limited. This systematic review aimed to evaluate the safety and efficacy of fondaparinux in HD patients with HIT.

METHODS

We searched PubMed/MEDLINE, Web of Science, Scopus, CENTRAL, ClinicalTrials.gov, and SCIndeks up to March 2, 2025. Eligible studies included clinical trials, observational studies, and case reports/series on fondaparinux use in adult HD patients with HIT. Data on demographics, clinical characteristics, diagnostics, dosing, administration routes, and outcomes were extracted and narratively synthesized.

RESULTS

Seventeen studies with 37 patients (aged 38-88 years) were included. Dosing regimens and monitoring strategies varied widely across dialysis modalities, with the most common initial fondaparinux dose being 2.5 mg/day. Platelet recovery was observed in most cases. Bleeding occurred in 10.8% of patients, thrombotic events in 5.4%, and overall mortality was 16.2%. Vascular access thrombosis was reported in two patients (5.4%) following the initiation of fondaparinux. Some clotting of the extracorporeal circuit was reported during select sessions in 7 patients undergoing non-continuous dialysis modalities (18.9%), including five on high-flux HD, one on unspecified intermittent HD, and one on post-dilution hemodiafiltration.

CONCLUSIONS

Fondaparinux may be a potential alternative anticoagulant in HD patients with HIT, especially when first-line agents are unavailable. However, its use should be approached with caution and tailored to individual clinical circumstances, pending confirmation of its safety, efficacy, and optimal dosing and monitoring through larger prospective studies.

摘要

背景

肝素诱导的血小板减少症(HIT)是一种严重的原发性高凝性疾病,对于经常接触肝素的血液透析(HD)患者而言尤其值得关注。磺达肝癸钠已成为一种潜在的替代抗凝剂,不过相关支持证据有限。本系统评价旨在评估磺达肝癸钠在患有HIT的HD患者中的安全性和有效性。

方法

我们检索了截至2025年3月2日的PubMed/MEDLINE、科学引文索引、Scopus、Cochrane系统评价数据库、ClinicalTrials.gov和SCIndeks。符合条件的研究包括关于磺达肝癸钠用于患有HIT的成年HD患者的临床试验、观察性研究以及病例报告/系列。提取了有关人口统计学、临床特征、诊断、给药剂量、给药途径和结局的数据,并进行叙述性综合分析。

结果

纳入了17项研究,共37例患者(年龄38 - 88岁)。不同透析方式的给药方案和监测策略差异很大,磺达肝癸钠最常见的初始剂量为2.5毫克/天。大多数情况下观察到血小板恢复。10.8%的患者发生出血,5.4%发生血栓事件,总死亡率为16.2%。在开始使用磺达肝癸钠后,有2例患者(5.4%)报告发生血管通路血栓形成。在7例接受非连续性透析方式的患者(18.9%)的特定透析时段报告了体外循环的一些凝血情况,其中5例接受高通量HD,1例接受未指明的间歇性HD,1例接受后置稀释血液透析滤过。

结论

对于患有HIT的HD患者,磺达肝癸钠可能是一种潜在的替代抗凝剂,尤其是在一线药物无法获得时。然而,在通过更大规模的前瞻性研究确认其安全性、有效性以及最佳给药剂量和监测方法之前,应谨慎使用并根据个体临床情况进行调整。

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